ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-000
FDA 510(k) clearance K111116 · decided 2011-09-09
Clearance details
- K-number
- K111116
- Device name
- ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-000
- Applicant
- Datex-Ohmeda
- Decision
- Substantially Equivalent
- Date received
- 2011-04-21
- Decision date
- 2011-09-09
- Days to decision
- 141 days
- Clearance type
- Traditional
- Product code
- CBK
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Madison, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators ( recall (Z-1226-2022) | GE Healthcare, LLC | 2022-06-06 |
| Replacement back up batteries distributed on or after April 1, 2019, for CARESCAPE R860, E recall (Z-1227-2022) | GE Healthcare, LLC | 2022-06-06 |
| GE Healthcare Engstrom Carestation, Engstrom Pro, Cart Only S/5 EC. GE model numbers 1505- recall (Z-1270-2015) | GE Healthcare | 2015-03-24 |
| GE Healthcare, Avance, Avance CS2, Aisys, Aespire View, and Engstrom. Intended for volume recall (Z-0010-2014) | GE Healthcare, LLC | 2013-10-15 |